FDA 483 - Biomat USA Inc - November 06, 2025

Biomat USA Inc, a Source Plasma Collection Center in Killeen, TX, was cited for failing to perform thorough investigations into unexplained discrepancies. This included an employee purposely entering false quality control results for donor eligibility testing and repeated failures to record cannula lot numbers for collected source plasma. The findings indicate significant issues with the firm's corrective and preventive action (CAPA) system and data integrity.